Research is defined as a systematic investigation designed to develop knowledge that can be generalized. If you plan to present or publish the work or otherwise share results of the study, it is probably research.
Are you planning on presenting the data of the project on human subjects at an academic conference, publish the data in an academic journal, or use the human subjects research data in a master’s thesis or doctoral dissertation?
If NO: your project is not considered research and does not require IRB review.
If YES: your project is considered research and requires IRB review. It may however be EXEMPT.
Note: If your project is not hypothesis-driven, does not use research protocols or methodologies, and the anticipated data is not intended for publication of an article in a newspaper or magazine, no IRB review is needed.
Note 2: If no public dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, you are advised to submit the project for IRB review and approval before initiating the research project.
Under the U. S. Department of Health and Human Services, Code 45 of Federal Regulations Part 46.102 (d) defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Human participants are defined as: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction (including online interaction) with the individual or (2) identifiable private information.
Does your project involve subjects/participants or data identifiable to specific human subjects? Some examples of subjects/participants include:
• individuals who are asked to complete questionnaires, participate in interviews, or whose behavior is observed in daily activities
• oral history interviewees whose subjective perceptions are studied
• students and teachers observed in the classroom for the study of various teaching methods or development of curricula
If NO: Your project does NOT need IRB approval.
If YES: Your project most likely needs IRB review.
Under the U.S. Department of Health and Human Services, 45 CFR 46.102 (f) a “human subject” is a living individual about whom an investigator (whether professional or student) conducting research obtains data or any identifiable private information through intervention or interaction with the individual.
Yes. In many cases, the instructor can complete a human subjects application for the “generic” project, detailing the kinds of procedures, recruitment, subjects, risks, benefits, etc. The Board then reviews and approves this application and delegates responsibility to the instructor to act as a proxy reviewer. Students in turn complete the application, or otherwise present sufficient information to the instructor so that s/he can make a judgment: does this project fall within the boundaries of what was approved, generically, by the IRB? If so, the project may proceed. If not, the student is referred to the Research Office to decide whether a separate application is needed.
Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review.
Examples of activities that may not need IRB review are:
• Data collection for internal departmental, school, or other University administrative purposes (e.g. teaching evaluations, course evaluations, outcomes assessment).
• If your research is a class project or term paper and will not be published in any form at any time.
• Reviews and Searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual.
Use the following guidelines to determine if your activities in the classroom are subject to IRB application and review. An IRB Request for Class Project Waiver form is required for notification purposes if all of the following are true:
a. The project is limited to surveys/questionnaires/interviews/observations of public behavior directly related to topics being studied in an official college course.
b. The above surveys/questionnaires/activities, etc. contain no sensitive personal questions (e.g., no questions about drug use, sexual behavior or attitudes, criminal activity, grades, medical history) or other personal information that could stigmatize an individual.
c. No identifying information is recorded to link a person with the data such that it could reasonably harm the individual’s reputation, employability, financial standing, or place them at risk for criminal or civil liability.
d. The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, minors, cognitively impaired individuals).
e. The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.
f. No New Mexico State University employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.
If ALL of these conditions are not met, or if your project does not fall into any of these categories, your project will require IRB notification and formal IRB approval before you can start with your project.
The following are examples of projects that do require IRB notification but are exempt from IRB review. Nonetheless, formal paperwork needs to be submitted to the IRB prior to the start of the project since the decision on the exempt status is the sole responsibility of the IRB.
• The study of or comparison among instructional techniques, curricula, or classroom management methods.
• The use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless this involves any one under the age of 18.
• The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is collected in a way that cannot be linked either directly or through identifiers to an individual.
1. ALL research with children, including adolescents, must be reviewed by the IRB. Children are considered a vulnerable research population under Title 45 CFR Part 46. They are less able to give fully-informed consent with respect to the research involved. Safeguard procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18.
2. Even in the case where a project is not subject for review, the instructor/faculty member is responsible to uphold all applicable (e.g., American Psychology Association, American Counseling Association, National Institute of Health, etc.) ethical standards and guidelines in course-related research activities when it comes to the treatment of human subjects.
3. It is the responsibility of the supervising instructor/faculty member to determine whether projects are subject to review. It is always best to err on the safe side and seek consultation from the IRB if a question arises regarding human subjects, research and classroom activities.
The IRB approves protocols with the understanding that the work will be conducted only by the investigators named in the application. If your colleagues would like to work on your project, you may modify your existing protocol by contacting the NMSU Office of Research Compliance. Otherwise, they must make their own application.
Yes. All research involving interaction with human subjects requires informed consent regardless of who the subjects are. There are exceptions to this rule: in some studies, subjects are not given complete information about all procedures or hypotheses because full prior knowledge would affect their responses. Deception of subjects must be justified in each case, and subjects should be provided with a full explanation or debriefing as soon as practicable. The Board does not routinely approve such projects (in particular we do not believe it is an appropriate exercise for undergraduate researchers), and prior explanation of risks must never be withheld.
Confidentiality means that information is private, but that it is possible for you, or a determined person familiar with your subjects and/or able to gain access to your data, to figure out a subject’s identity. Anonymity means that it is impossible for you–or anyone else–to connect a subject with the data they’ve provided. Common conditions that make data confidential rather than anonymous include:
- the use of audiotapes to record interviews
- demographic data such as date of birth; use of small descriptive categories, e.g. black female senior official in a police department, Asian male executive nurse in a healthcare organization
- qualitative studies of few subjects with highly individual information, e.g. three school teachers describing what drew them to teaching, or their assessment of their school’s principal
- the use of ID numbers on subjects’ data with a separate name/number list
Investigators and laboratory or department heads are responsible for reporting promptly to the Board any serious or continuing noncompliance with university policies or federal regulations. In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to subjects be reported to the Board.
Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project.